Votubia everolimus regulatory update

The European Commission approved Votubia everolimus to treat renal angiomyolipoma associated with tuberous sclerosis complex (TSC) in adults who are at risk of complications but who do not require immediate surgery. Novartis markets everolimus as Afinitor in the U.S. and EU to treat advanced renal cell carcinoma, neuroendocrine tumors of pancreatic origin and renal angiomyolipomas (non-cancerous kidney tumors), and as Afinitor in the U.S. and as Votubia in the EU to treat subependymal giant cell astrocytoma (SEGA) associated with TSC who require therapeutic intervention but are not amenable to surgery. The pharma also markets everolimus as Certican to prevent transplant rejection in over 80 countries, and as Zortress in the U.S. to prevent organ rejection of kidney transplants in adults. Everolimus has Orphan Drug status in the U.S. to treat renal angiomyolipomas and SEGA associated with TSC. ...